ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is the gold standard for medical device manufacturers worldwide.
Who Needs ISO 13485?
Medical device manufacturers, suppliers, distributors, and service providers. Essential for CE Marking in Europe, FDA compliance in the USA, and market access in Canada, Japan, Australia, and other regulated markets.
Key Benefits
- Demonstrate compliance with global medical device regulations
- CE Marking prerequisite for European market access
- Enhanced product quality and patient safety
- Streamlined regulatory audits and inspections
- Reduced risk of product recalls and adverse events
- Competitive advantage in tenders and procurement
Key Requirements
- Quality management system documentation and records
- Management responsibility and resource management
- Product realization - design, purchasing, production, servicing
- Measurement, analysis, and improvement processes
- Risk management throughout product lifecycle (ISO 14971)
- Validation of processes, software, and sterile devices
- Traceability and complaint handling procedures
- Post-market surveillance and vigilance reporting
Our Support
- Gap analysis against ISO 13485 and applicable regulations
- Quality Manual, procedures, and technical file preparation
- Design Dossier and Device Master Record development
- Clinical evaluation and biocompatibility guidance
- Internal audits and management review facilitation
- Notified Body coordination for CE Marking